WASHINGTON -- As Congress continues its summer break, top brass at the Department of Health and Human Services and the National Institutes of Health press lawmakers for more Zika funding.
Fauci: More $$ From Congress Still Needed for Zika
Without more money from Congress, ongoing research on Zika vaccine candidates might have to be delayed, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said Thursday.
"We asked for $277 million for a comprehensive NIH [National Institutes of Health] approach to Zika," Fauci said. As he was speaking, Health and Human Services Secretary Sylvia Burwell was releasing a letter she sent to members of Congress telling them that she was authorizing the NIH to transfer $34 million from other NIH agencies to NIAID's Zika vaccine development.
"The money the secretary is allowing us to get by transfer is [going toward] preparing sites for phase II trials for one [vaccine] candidate," Fauci said at a briefing on Zika sponsored by Health Affairs, the Alliance for Health Reform, and the Jayne Koskinas Ted Giovanis Foundation for Health and Policy. "We still need about $196 million more. Otherwise, second, third, and fourth candidates will get not only slowed down, we won't be able to start them." NIH announced on Aug. 3 that it had begun phase I testing of a gene-based vaccine.
He emphasized that getting the money by taking it from other NIH divisions -- rather than getting a new allocation from Congress -- was not a positive development.
UNOS/OPTN Propose New Liver Allocation Plan
Liver transplantation might become more equitable under an allocation program being considered by the United Network for Organ Sharing (UNOS) and the Organ Procurement and Transplantation Network (OPTN).
The proposed plan, which will be released for public comment on Aug. 17, would change the geographic regions in which livers are allocated throughout the U.S. Under the current system, the country is divided into 11 different regions, and organs are allocated within each region based on how sick the patients on the transplant list are.
However, the regions vary greatly in terms of size and also vary a lot in terms of how many patients are waiting for transplants and how many potential donors there are, explained Ryutaro Hirose, MD, chair of the Liver and Intestinal Committee at OPTN, on a call with reporters.
In addition, the degree of illness that's required to get a transplant -- which is determined based on a 40-point scale known as a MELD score -- varies greatly from region to region, explained Hirose, who is also an organ transplant surgeon at the University of California San Francisco.
FDA Commissioner: Cardiology Can Do Better
Cardiologists should take advantage of new tools available for collecting high-quality data, according to the head of the FDA.
"We are now entering a new era in medicine that is characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices," Robert M. Califf, MD, commissioner of food and drugs at the agency, wrote online in the Journal of the American College of Cardiology.
"The FDA is responding to this changing world. However, we believe the needed changes must involve not only the FDA but the entire ecosystem of which the FDA is a part. As we work together to shape the future of medicine, cardiovascular specialists will play a special role."
With a minority of guidelines actually supported by high-quality evidence -- 15%, Califf estimated -- the cardiovascular community can do better. "Dramatic improvements in the rate, quantity, and quality of evidence generation are within reach. Almost all Americans now have electronic health records, and social media combined with wearable devices are opening new frontiers in patient- and population-level data," he wrote, adding that registries are "proliferating."
He added that data is also sorely needed for underserved populations like neonates, pregnant women, and the elderly. What's more, little remains known about why access and adherence to cardiovascular medicine is limited in low-income communities.
Next week
Congress remains in recess until after Labor Day.
On Monday, the FDA holds a meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA).
On Tuesday, the FDA's Microbiology Devices Panel of the Medical Devices Advisory Committee meets to discuss the potential for over-the-counter diagnostic tests used to detect pathogens causing infectious diseases, primarily respiratory and sexually transmitted infections.